CRANBURY, N.J.—Amicus Therapeutics and Glaxo Group Limited(GSK) have announced the expansion of their collaboration, which was previouslyestablished for the development and commercialization of the investigationalpharmacological chaperone migalastat HCl for Fabry disease. The expandedalliance covers co-development of all current and future formulations ofmigalastat HCl for Fabry disease, including a co-formulation of the compoundwith GSK/JCR Pharmaceutical Co., Ltd.'s investigational enzyme replacementtherapy (ERT) for Fabry disease.
Per the terms of the expanded agreement, Amicus willcommercialize all formulations of migalastat HCl in the United States, whileGSK will handle commercialization in the rest of the world. The companies willcontinue to share R&D costs, with Amicus funding 25 percent and GSK 75percent of the costs for monotherapy and co-administration for the remainder of2012. Amicus will be responsible for 40 percent and GSK 60 percent of the costsfor co-formulation immediately, and for all other formulations in from 2013onwards. GSK will make an $18.6 million equity investment in Amicus, increasingits ownership stake in Amicus to 19.9 percent, and GSK will purchase 2,949,581shares of Amicus stock at $6.30 per share.
Amicus will receive $3.5 million from GSK for a clinicalmilestone, and GSK will be eligible to receive U.S. regulatory approval andproduct launch milestones of $20 million for migalastat HCl monotherapy andchaperone-ERT co-administration. GSK will also be eligible to receiveregulatory and time-based milestone payments up to $35 million within sevenyears of the launch of a co-formulated chaperone-ERT product, and Amicus willbe eligible for certain additional milestones and single-digit royalties on netU.S. sales of the co-formulated chaperone-ERT product.
"We have strengthened our relationship with Amicusthrough the expanded Fabry collaboration and additional equity investment inthe Company," Marc Dunoyer, global head of GSK Rare Diseases, said in apress release. "Amicus has a very successful track record as ourdevelopment partner, and long-standing relationships with the Fabry community.We look forward to their leadership in the U.S. commercialization of nowseveral potential medicines for patients with Fabry disease. This is animportant step in our strategic vision, allowing us to undertake and fund anenlarged scientific program with a view to turning molecules into medicines forrare diseases faster and more effectively than ever before."
The companies are working on the parallel development ofthree different uses for the therapy in treating Fabry disease: migalastat HClas a monotherapy, which is currently in Phase III global registration studies;migalastat HCl co-administered with ERT in a Phase II study; and migalastat HClco-formulated with a proprietary preclinical ERT, in which Amicus and GSK arecollaborating with JCR to co-formulate migalastat HCl with a proprietaryrecombinant human alpha-Gal A enzyme (JR-051).
"GSK has added significant value to the Fabry programthrough its global scale and capabilities as well as the dedicated focus of GSKRare Diseases," John F. Crowley, chairman and CEO of Amicus, said in a pressrelease. "Through our expanded agreement, GSK is increasing its investment inthe Fabry development program and Amicus is transforming into acommercial-stage biopharmaceutical company within the U.S. Amicus is leveragingits chaperone-ERT platform to advance migalastat HCl in multiple potential usesfor patients with Fabry disease."
SOURCE: Amicus press release
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